Quality Evaluation of Gegen Qinlian Tablets Based on HPLC Multi-component Quantification Combined with Chemical Pattern Recognition and TOPSIS Analysis
10.13422/j.cnki.syfjx.20251966
- VernacularTitle:基于HPLC多成分定量测定结合化学模式识别及TOPSIS分析的葛根芩连片质量评价
- Author:
Ping QIN
1
;
Yingying LU
1
;
Wenming ZHANG
1
;
Zifang FENG
1
;
Lihong GU
1
;
Chenjie XIA
1
;
Minmin HU
1
;
Xiaowei CHEN
1
;
Zhenhua BIAN
1
;
Xiwan LU
1
Author Information
1. Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine，Wuxi 214071，China
- Publication Type:Journal Article
- Keywords:
Gegen Qinlian tablets;
chemical pattern recognition;
technique for order preference by similarity to ideal solution（TOPSIS）;
quality evaluation;
puerarin;
berberine;
baicalin
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(6):217-224
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo establish a high-performance liquid chromatography（HPLC） for the quantitative analysis of multiple components in Gegen Qinlian tablets， and to comprehensively evaluate the quality of samples from different manufacturers by integrating chemical pattern recognition and technique for order preference by similarity to ideal solution（TOPSIS）， in order to provide a reference basis for quality evaluation and control of Gegen Qinlian tablets. MethodsHPLC was employed to determine the contents of 10 components in 28 batches of Gegen Qinlian tablets collected from 6 manufacturers， and taking the detection results as variables， SIMCA 14.1 and SPSS 26.0 were employed for cluster analysis（CA）， principal component analysis（PCA）， and orthogonal partial least squares-discriminant analysis（OPLS-DA） to identify key components affecting the quality. Then， TOPSIS analysis was employed to rank the quality of Gegen Qinlian tablets from the 6 manufacturers and establish a comprehensive quality evaluation method. ResultsA quantitative method for Gegen Qinlian tablets was established. After methodological validation， the method was found to be stable and reliable， and could be used for the quantitative analysis of this preparation. The contents of 3′-hydroxy puerarin， puerarin， 3′-methoxy puerarin， daidzein， coptisine hydrochloride， epiberberine， jatrorrhizine hydrochloride， berberine hydrochloride， palmatine hydrochloride and baicalin in 28 batches of samples were 3.58-7.35， 24.88-42.32， 4.20-9.36， 4.33-7.60， 2.52-6.44， 0.93-4.10， 0.58-3.05， 10.68-22.92， 0.82-4.82， 11.73-60.16 mg·g-1， respectively. Among them， puerarin， berberine hydrochloride and baicalin all met the limit requirements for this preparation specified in the 2025 edition of the Pharmacopoeia of the People's Republic of China. CA and PCA clustered the 28 batches of samples into 5 categories， PCA extracted 2 principal components with a cumulative variance contribution rate of 90.588%， and OPLS-DA screened out 4 differential markers with variable importance in the projection（VIP） values>1.0， namely baicalin， 3′-hydroxy puerarin， coptisine hydrochloride and palmatine hydrochloride， which might be the main components affecting the quality of Gegen Qinlian tablets. TOPSIS analysis showed that the comprehensive score of each evaluation index（Ci） values of different manufacturers were different. Among them， the Ci of manufacturer B was ranked higher， indicating potentially superior quality， while the Ci of manufacturer A was ranked lower， suggesting potentially inferior quality. ConclusionThis study establishes a quantitative method for Gegen Qinlian tablets， and the content uniformity of the same manufacturer is good， while there are differences in the contents of active components among different manufacturers. Through the chemical pattern recognition analysis， it is found that the content differences of Gegen Qinlian tablets may be related to baicalin， 3′-hydroxy puerarin， coptisine hydrochloride and palmatine hydrochloride.
